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Powerwand™ Xl

FDA UDI

Class II (US FDA UDI)

by Access Scientific, Inc.

Identity

Trade Name
POWERWAND™ XL FDA UDI
Generic Name
Peripheral vascular catheter FDA UDI
Device Name
POWERWAND™ XL Alt Site Kit 5Fr X 8cm FDA UDI
Model / Reference
Alt Site Kit 5Fr X 8cm FDA UDI
Description
POWERWAND™ XL Alt Site Kit 5Fr X 8cm FDA UDI

Identifiers

Catalog Number
80702 FDA UDI
Primary DI / UDI-DI
10859821006244 FDA UDI
FDA Product Code
OWL FDA UDI
GMDN Term
Peripheral vascular catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 8 Centimeter FDA UDI
Catheter Gauge — 5 French FDA UDI

Category: Peripheral vascular catheter

Powerwand™ Xl by Access Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral vascular catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Access Scientific, Inc.

Sources (1)

  • FDA UDI 0fc0d86a-d721-41e4-b400-3f41199fa251 37 fields · synced Jun 8, 2026